IMPACT: Inactivity Monitoring and Physical Activity Controlled Trial
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer, Obesity Weight Loss, Peripheral Vascular Disease, Orthopedic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Oncology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 55 - 79 |
| Updated: | 10/6/2017 |
| Start Date: | June 2014 |
| End Date: | April 15, 2016 |
As individuals age, their physical activity decreases and sedentary time increases. Even
small changes in these two behaviors can greatly decrease risks for several major health
problems, including cardiovascular disease, diabetes, and many cancers. Studies that use
pedometers to encourage walking have successfully increased physical activity, but do not
address sedentary behaviors such as television watching. The investigators propose to use a
novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and
decreased sedentary time. First, the investigators will recruit 10 adults to participate in a
brief intervention for six weeks. They will wear the wrist-based activity monitor and use a
mini-tablet device to see feedback on their activity and sedentary time. They will also
receive brief counseling weekly. The investigators will use this first study to investigate
the basic feasibility of the intervention materials. Next, the investigators will recruit 20
adults and randomize them to receive the intervention for 12 weeks or to a waiting list.
Here, the investigators will test the intervention with refinements made based on participant
responses from the first small study. Our primary outcomes will be measures of feasibility
and acceptability across all parts of the study. The investigators hypothesize that the
intervention will be feasible and acceptable to the participants. The investigators will also
measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings
of motivation.
small changes in these two behaviors can greatly decrease risks for several major health
problems, including cardiovascular disease, diabetes, and many cancers. Studies that use
pedometers to encourage walking have successfully increased physical activity, but do not
address sedentary behaviors such as television watching. The investigators propose to use a
novel pedometer-like device (Jawbone Up) that encourages both increased physical activity and
decreased sedentary time. First, the investigators will recruit 10 adults to participate in a
brief intervention for six weeks. They will wear the wrist-based activity monitor and use a
mini-tablet device to see feedback on their activity and sedentary time. They will also
receive brief counseling weekly. The investigators will use this first study to investigate
the basic feasibility of the intervention materials. Next, the investigators will recruit 20
adults and randomize them to receive the intervention for 12 weeks or to a waiting list.
Here, the investigators will test the intervention with refinements made based on participant
responses from the first small study. Our primary outcomes will be measures of feasibility
and acceptability across all parts of the study. The investigators hypothesize that the
intervention will be feasible and acceptable to the participants. The investigators will also
measure physical activity, sedentary behavior, fitness, body fat, and psychological feelings
of motivation.
Inadequate physical activity and extended bouts of sedentary time are prevalent in adults,
increasing from middle age into older adulthood. Even small changes in behavior, such as
standing or walking in place periodically to break up sedentary bouts, can have large effects
on cardiometabolic risk factors. Pedometer-based walking interventions have demonstrated
effectiveness in increasing physical activity in this population, but these interventions
have not targeted sedentary behavior. Recent technological advances have produced activity
monitors that are capable of intervening on both behaviors. These wrist-worn monitors provide
feedback and motivation for walking as well as cues to action in the form of idle alerts.
These idle alerts vibrate when the wearer has remained sedentary for an extended period of
time. Several preliminary studies have shown that older adults are willing to break up their
sedentary time if prompted, but interventions thus far have relied upon television
commercials as a cue to action. Use of these monitors would allow idle alerts to occur
throughout the day, not only during television watching periods. The purpose of the IMPACT
study (Inactivity Monitoring and Physical Activity Controlled Trial) is to investigate the
feasibility of using activity monitors to simultaneously target both physical activity and
sedentary behavior. First, we will conduct a pre-pilot test (N = 10) over six weeks. This
brief study will provide basic feasibility and acceptability information on the monitor,
content for weekly sessions, and assessments. Results will be used to refine the intervention
for use in a larger pilot two-arm randomized controlled trial (N = 20, 12 weeks). This trial,
comparing the intervention to a wait-list control group, will test feasibility,
acceptability, and health, behavioral, and psychological outcomes. The primary outcome will
be physical activity, operationalized as objectively-measured minutes of moderate-vigorous
intensity physical activity over seven days (SenseWear armband). We will also measure
cardiorespiratory fitness, physical function, body composition, and psychosocial variables
such as autonomous motivation. The results of this innovative project will provide a
foundation for future intervention in sedentary behavior and potentially create a large
public health impact in a population at unique risk.
increasing from middle age into older adulthood. Even small changes in behavior, such as
standing or walking in place periodically to break up sedentary bouts, can have large effects
on cardiometabolic risk factors. Pedometer-based walking interventions have demonstrated
effectiveness in increasing physical activity in this population, but these interventions
have not targeted sedentary behavior. Recent technological advances have produced activity
monitors that are capable of intervening on both behaviors. These wrist-worn monitors provide
feedback and motivation for walking as well as cues to action in the form of idle alerts.
These idle alerts vibrate when the wearer has remained sedentary for an extended period of
time. Several preliminary studies have shown that older adults are willing to break up their
sedentary time if prompted, but interventions thus far have relied upon television
commercials as a cue to action. Use of these monitors would allow idle alerts to occur
throughout the day, not only during television watching periods. The purpose of the IMPACT
study (Inactivity Monitoring and Physical Activity Controlled Trial) is to investigate the
feasibility of using activity monitors to simultaneously target both physical activity and
sedentary behavior. First, we will conduct a pre-pilot test (N = 10) over six weeks. This
brief study will provide basic feasibility and acceptability information on the monitor,
content for weekly sessions, and assessments. Results will be used to refine the intervention
for use in a larger pilot two-arm randomized controlled trial (N = 20, 12 weeks). This trial,
comparing the intervention to a wait-list control group, will test feasibility,
acceptability, and health, behavioral, and psychological outcomes. The primary outcome will
be physical activity, operationalized as objectively-measured minutes of moderate-vigorous
intensity physical activity over seven days (SenseWear armband). We will also measure
cardiorespiratory fitness, physical function, body composition, and psychosocial variables
such as autonomous motivation. The results of this innovative project will provide a
foundation for future intervention in sedentary behavior and potentially create a large
public health impact in a population at unique risk.
Inclusion Criteria:
1. Willing to be randomized to either group
Exclusion Criteria:
1. Age below 55 or above 79
2. Unable to read and understand English
3. Unable to read words in standard applications on a mobile device 5 - 10" large
4. Unable to find transportation to the study location
5. Investigator overseeing initial fitness test does not approve participation in the
study
6. Report a heart condition, chest pain during periods of activity or rest, or loss of
consciousness on the Physical Activity Readiness Questionnaire (PAR-Q, items 1 - 4).
Reporting taking medicine for blood pressure on this questionnaire will require a
doctor's note to participate.
7. Unable to walk for exercise (self-report)
8. Report current symptoms of alcohol or substance dependence
9. Plans to move away from the Galveston-Houston area or to be out of town for more than
1 week during the study period
10. Unwillingness to report drugs taken for comorbidities such as hypertension or diabetes
11. Stroke, hip fracture, hip or knee replacement, or spinal surgery in the past 6 months
12. Participant is active (60 minutes of moderate-vigorous intensity activity per week or
more)
13. Participant watches little television (120 minutes per day or less)
14. BMI is under 25 kg/m2 or over 35 kg/m2
15. Another member of the household is a participant or staff member on this trial
16. Currently a participant in a physical activity research trial
17. Recently (less than six months ago) completed a physical activity research trial
18. Report a history of orthopedic complications that would prevent optimal participation
in the physical activities prescribed (e.g., heel spurs, severe arthritis - may be
eligible, but a doctor's note will be required)
19. Current smoker
20. Currently uses a Jawbone Up or similar activity monitor device
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